Department of Pharmacology, CHRU of Tours, Bretonneau Hospital, Regional Centre of Pharmacovigilance, France.
Eur J Clin Pharmacol. 2010 Apr;66(4):413-7. doi: 10.1007/s00228-009-0769-6. Epub 2009 Dec 19.
The aim of this case/non-case study was to assess and compare the risk of drug dependence associated with different migraine-specific drugs, i.e., ergot derivatives and triptans, using the French pharmacovigilance database.
Reports on drug side effects recorded in this database between January 1985 and June 2007 were analyzed, and triptans (almotriptan, eletriptan, naratriptan, sumatriptan, and zolmitriptan) as well as ergot derivatives used in acute migraine were examined. For all reports, cases were defined as those reports corresponding to "drug abuse," "physical or mental drug dependence," and "pharmacodependence," whereas "non-cases" were defined as all the remaining SED reports. The method's reliability was assessed by calculating the risk associated with a negative (amoxicillin) and a positive (benzodiazepines) control. The risk of dependence associated with each drug and control was evaluated by calculating the odds ratio (OR) with a confidence interval of 95%.
Among the 309,178 reports recorded in the database, drug dependence accounted for 0.8% (2,489) of the reports, with 10.9% (449) involving a triptan, and 9.33% (332) an ergot derivative. The risk of dependence was similar for triptans and ergot derivatives and did not differ from that of benzodiazepines. In the triptan group, the risk (odds ratio [95% CI]) ranged from 10.3 [4.8-22.3] for sumatriptan to 21.5 for eletriptan [10.1-45.6], while in the ergot derivative group, it ranged from 12 [8-17.9] for ergotamine to 20.6 [8-53] for dihydroergotamine.
These findings confirm the hypothesis that triptans and ergot derivatives are associated with an increased risk of drug dependence.
本病例/非病例研究旨在使用法国药物警戒数据库评估和比较不同偏头痛专用药物(即麦角生物碱和曲坦类药物)相关药物依赖风险。
分析了该数据库中记录的 1985 年 1 月至 2007 年 6 月药物副作用报告,检查了曲坦类药物(阿莫曲坦、依来曲坦、那拉曲坦、舒马曲坦和佐米曲坦)和急性偏头痛使用的麦角生物碱衍生物。对于所有报告,病例定义为与“药物滥用”、“身体或精神药物依赖”和“药物依赖性”相对应的报告,而非病例定义为所有剩余的 SED 报告。通过计算阴性(阿莫西林)和阳性(苯二氮䓬类)对照的风险来评估方法的可靠性。通过计算比值比(OR)及其 95%置信区间评估每种药物和对照药物的依赖风险。
在数据库记录的 309,178 份报告中,药物依赖占报告的 0.8%(2,489),其中 10.9%(449)涉及曲坦类药物,9.33%(332)涉及麦角生物碱衍生物。曲坦类药物和麦角生物碱衍生物的依赖风险相似,与苯二氮䓬类药物无差异。在曲坦类药物组中,风险(比值比[95%CI])范围从舒马曲坦的 10.3[4.8-22.3]到依来曲坦的 21.5[10.1-45.6],而在麦角生物碱衍生物组中,风险范围从麦角胺的 12[8-17.9]到二氢麦角胺的 20.6[8-53]。
这些发现证实了曲坦类药物和麦角生物碱衍生物与药物依赖风险增加相关的假设。